Informational only — Not medical advice. Always consult a licensed healthcare provider.

Community data Updated 23 hours ago

Indications

Coagulation Factor IX (Recombinant) is a human blood coagulation factor. Adults and children aged 12 years and above who have hemophilia B can use it for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes. It is not indicated for induction of immune tolerance in patients with hemophilia B.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Hemophilia B is a hereditary, sex-linked disorder of blood clotting. It happens because the body is short of factor IX. People with the condition can bleed into their joints, muscles or internal organs, sometimes without any obvious cause and sometimes after an accident or surgery. Coagulation Factor IX replaces the missing factor IX, so the deficiency is corrected for a time and the tendency to bleed is corrected with it.

Pregnancy & Breastfeeding

There are no data on the use of coagulation factor IX in pregnant women, so any risk linked to the medicine is unknown. Animal reproduction studies have not been done with coagulation factor IX either. In the U.S. general population, the estimated background risk of major birth defect is 2-4% and of miscarriage is 15-20% in clinically recognized pregnancies.

Nothing is known about whether coagulation factor IX passes into human milk, what effect it has on a breastfed infant, or whether it affects milk production. When deciding, weigh the developmental and health benefits of breastfeeding against the mother's clinical need for coagulation factor IX. Also consider any possible adverse effects on the breastfed infant, whether from the medicine or from the mother's underlying condition.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Coagulation Factor IX is for intravenous use only, and only after it has been reconstituted. It is used for on-demand treatment and control of bleeding episodes, and for managing bleeding around surgery. One international unit (IU) of coagulation factor IX per kg body weight raises the circulating factor IX activity by 0.98 IU/dL. For the initial dose, the number of factor IX units needed (IU) is worked out as body weight (kg) x desired factor IX increase (% of normal or IU/dL) x the reciprocal of the observed recovery (IU/kg per IU/dL). The maintenance dose depends on the type of bleed or surgery, how serious the hemostatic challenge is, and how many days are needed until the wound has healed adequately. Pediatric use: The safety and effectiveness of coagulation factor IX have not been established in children below 12 years of age. Geriatric use: Clinical studies of coagulation factor IX did not include anyone aged 65 and over. It isn't known whether elderly patients respond differently from younger patients. The dose for elderly patients should be individualised.